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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA); DENTURE ADHESIVE

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GLAXOSMITHKLINE DUNGARVAN LTD SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA); DENTURE ADHESIVE Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
Argus id case: (b)(4).
 
Event Description
It caused blindness in me / yes its causing me blindness.I used to be able to see now i can't see anymore [blindness], i think i have alzheimer's because of this [alzheimer's disease], i'm going to see a foot dr later today [foot discomfort], causing me high blood pressure [blood pressure high], i got hemorrhoids too [hemorrhoids], i put in tweezer head and a paper clip [wrong technique in device usage process].Case description: this case was reported by a consumer via call center representative and described the occurrence of blindness in a male patient who received double salt dental adhesive cream (super poligrip original (zinc free formula)) cream (batch number unk, expiry date unknown) for denture failure.This case was associated with a product complaint.Concurrent medical conditions included implantable defibrillator user and heart disorder.Concomitant products included no therapy.On an unknown date, the patient started super poligrip original (zinc free formula).On an unknown date, an unknown time after starting super poligrip original (zinc free formula), the patient experienced blindness (serious criteria gsk medically significant and other: gsk medically significant), alzheimer's disease (serious criteria gsk medically significant and other: gsk medically significant), foot discomfort, blood pressure high, hemorrhoids, wrong technique in device usage process and product complaint.The action taken with super poligrip original (zinc free formula) was unknown.On an unknown date, the outcome of the blindness, alzheimer's disease, foot discomfort, blood pressure high, hemorrhoids, wrong technique in device usage process and product complaint were unknown.The reporter considered the blindness to be related to super poligrip original (zinc free formula).It was unknown if the reporter considered the alzheimer's disease, foot discomfort, blood pressure high, hemorrhoids and wrong technique in device usage process to be related to super poligrip original (zinc free formula).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: the case was reported by consumer via call center representative on 24 mar 2021.The patient stated that "customer i uh use the poligrip super strong poligrip i am having a problem with it me just me i'm a happy user of poligrip i have a partial plate i was on a trip with a new tube and it was less than 10% used and i uh go to squeeze it and it was real hard and clear liquid came out instead of the pink stuff and i put in tweezer head and a paper clip and when i press on it feels the part up at the top is hard as a rock and the bottom is loose and pliable.So, i think i got a defective poligrip this time around.Do you have like a product number or something you want.Ya, it wouldn't come out ya, it had come out for about 10% you know what i mean.When i went to use it one day it wouldn't come out when i went to squeeze it.Then clear liquid bubbles then i put like an end up a q tip tweezer then that one worked so i stuck a paper clip down its hard and i pulled pieces out and it won't come out but the back part of the tube i can feel its soft the front it feels like a rock.Its solidified its not coming out.It feels hard.Ya all this if you want my medical i would have to go with the hippa laws here's what i have to keep it simple for ya ummm i have a product i used over time it used over time i bought it it usually works this one is clogged up.I think you should replace it or give me my money back or do something.I don't feel comfortable going through my medical history.You know what well i'm getting aggravated now i had a lot of problems with this i think you should give me my money back or send me a coupon for a new one cause i use your product and this one doesn't work.I think you'd be more interested in i can't even see it here a number or something so you can check the batch and not send bad products out to a lot of people but that might not be what you care about but i'm getting disgusted with this call.Yes, i do you know what it caused blindness in me now i think i have alzheimer's because of this, and i'm going to call my lawyer and sue ya does that make ya happy.Just replace the tube.Where am i calling.It says my grandmother was born there; you have the corporate headquarters where someone can get some service.Ya whoever can help me.Without having to go through a lot of medical bullcrap.How brief is a hold going to be? you'd think this would be an easy do for ya.I got a bad product.You'd think you'd replace the product.This is outrageous.No, you weren't.You want all kind of medical things, the fact that i have a complain a defibrillator has nothing to do with your clogged up tube the fact that i have an implanted defibrillator for a heart condition and some other things and in fact i'm going to see a foot dr later today.Yes, yes, it is causing me blindness.I used to be able to see now i can't see anymore.Causing me high blood pressure and i hate to tell ya i got hemorrhoids too.Give me the manager you're impossible.Ya i bet you will".Pqc evaluation: evaluation from the quality assurance department for 01869939.No sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.The complaint stands inconclusive.
 
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Brand Name
SUPER POLIGRIP ORIGINAL (ZINC FREE FORMULA)
Type of Device
DENTURE ADHESIVE
Manufacturer (Section D)
GLAXOSMITHKLINE DUNGARVAN LTD
dungarvan, waterford
EI 
Manufacturer Contact
po box 13398
research triangle park, NC 27709
8888255249
MDR Report Key11716114
MDR Text Key263438133
Report Number3003721894-2021-00119
Device Sequence Number1
Product Code KOT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/24/2021
Initial Date FDA Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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